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Botulinum Toxin for Stomach Cancer Treatment

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ClinicalTrials.gov Identifier: NCT01822210
Recruitment Status : Completed
First Posted : April 2, 2013
Last Update Posted : March 9, 2018
Sponsor:
Collaborator:
Norwegian University of Science and Technology
Information provided by (Responsible Party):
St. Olavs Hospital

Study Description
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Brief Summary:
Preclinical studies at our institution, using a genetic mouse model of gastric cancer, strongly suggest that innervation of the stomach wall is required not only for the development, but also for the progression of gastric cancer, and that denervation of the stomach either by vagotomy or by injection of botulinum toxin (Botox®) in the stomach wall may represent an effective therapeutic intervention. New treatment options for inoperable cancer in the stomach are urgently needed, and local treatment with botulinum toxin seems to be an attractive possibility. In this pilot study Botox injections will be given by gastroscopy in both the tumor and the surrounding stomach wall. The purpose of the study is to obtain data needed to calculate sample size in a larger controlled trial.

Condition or disease Intervention/treatment Phase
Stomach Neoplasms Drug: Botox Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Botulinum Toxin (BOTOX) for Stomach Cancer Treatment
Actual Study Start Date : January 2013
Actual Primary Completion Date : May 2016
Actual Study Completion Date : May 2016

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Botox
Injection of Botox in the tumor and surrounding stomach wall.
 Drug: Botox
injection by gastroscopy (100 Allergen units)
Other Name: Botulinum toxin


Outcome Measures
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Primary Outcome Measures :
  1. Change of tumor volume in the stomach. [ Time Frame: Baseline and 8 weeks ]
    Change measured with a standardized CT protocol (Thickness of the stomach wall and diameter of the tumor).

  2. Change of tumor volume in the stomach. [ Time Frame: 8 weeks and 20 weeks ]
    Change measured with a standardized CT protocol (Thickness of the stomach wall and diameter of the tumor).


Secondary Outcome Measures :
  1. Toxicity [ Time Frame: 2 weeks ]
    Assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 4.0

  2. Toxicity [ Time Frame: 8 weeks ]
    Assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 4.0

  3. performance status [ Time Frame: 2 weeks ]
    ECOG scale

  4. performance status [ Time Frame: 8 weeks ]
    ECOG scale

  5. performance status [ Time Frame: 20 weeks ]
    ECOG scale


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

Patients with verified gastric adenocarcinoma but found non-resectable or inoperable after evaluation in the appropriate multidisciplinary team at St.Olav Hospital. Trondheim University Hospital. The inclusion criteria for such patients are:

  1. Patients who have received 1.line and 2. line chemotherapy but no longer respond to such therapy.
  2. Patients who, due to toxicity of chemotherapy, cannot be offered such treatment.
  3. Patients who, after meticulous information about chemotherapy, still do not want such treatment.
  4. Patients with performance status (ECOG) 0-2.

Exclusion criteria:

  1. Known allergy to any of the components in Botox®
  2. Known peripheral motor neuropathy disease ( for example: Amyotrophic Lateral Sclerosis, ALS), or subclinical or clinical deficiency of neuromuscular transmission (for example: Myasthenia Gravis or Eaton-Lambert's Syndrome).
  3. Pregnant or lactating women.
  4. Another cancer disease that is not under control.
  5. Another concomitant treatment for cancer.
  6. Serious mental illness.
  7. Performance status (ECOG) 3-4.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01822210


Locations
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Norway
Department of Gastrointestinal Surgery, St Olavs Hospital Trondheim University Hospital
Trondheim, Norway
Sponsors and Collaborators
St. Olavs Hospital
Norwegian University of Science and Technology
Investigators
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Principal Investigator: Jon Erik Grønbech, MD. PhD. St. Olavs Hospital
More Information
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Publications of Results:
Andersen G, Zhao CM, Cai X, Rabben HL, Fox JG, Wang TC, Chen D, Gronbech JE. Tu1418 Intragastric Injection of Botulinum Toxin a to Treat Gastric Cancer: An Open-Label Phase II Clinical Trial. Gastroenterology 150: S1251-1252, 2016 https://doi.org/10.1016/S0016-5085(16)34227-5

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Responsible Party: St. Olavs Hospital
ClinicalTrials.gov Identifier: NCT01822210    
Other Study ID Numbers: StOlav2205
2012-002493-31 ( EudraCT Number )
First Posted: April 2, 2013    Key Record Dates
Last Update Posted: March 9, 2018
Last Verified: March 2018
Keywords provided by St. Olavs Hospital:
Botulinum Toxins
Injections
Stomach
Tomography, X-Ray Computed
Additional relevant MeSH terms:
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Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
 Botulinum Toxins
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs